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A Study of Afimkibart for Moderate to Severe Rheumatoid Arthritis

This study is testing a new medication called Afimkibart (also known as RO7790121) for people with moderate to severe rheumatoid arthritis (RA). RA is a condition where your immune system attacks your joints, causing pain and swelling. You might be able to join if your RA hasn't improved enough with, or you can't tolerate, other common RA medications like TNF inhibitors or JAK inhibitors. The study will compare Afimkibart to a placebo (an inactive substance) to see if Afimkibart is effective and safe. Researchers will measure changes in your disease activity, specifically using a score called DAS28-CRP, at 14 weeks to see how well the treatment is working. The study aims to enroll about 160 participants, but its current recruitment status is unclear.

Study design
This is an interventional study comparing Afimkibart to a placebo. It plans to enroll about 160 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at Week 14, indicating follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07137598

A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Hoffmann-La Roche
~160 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:AfimkibartPlacebo

At a glance

Recruiting sites
63 of 63 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP)
Measured over Baseline, At Week 14

Conditions

Rheumatoid Arthritis

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Rheumatoid Arthritis

Where it's being run

63 sites across 44 states
Poland8
California3
Texas3
Spain3
Buenos Aires2
Argentina2
Belgium2
São Paulo2

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: WA45846 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. and Canada)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Has moderate to severe active RA defined by the presence of \>=6 swollen joints and \>=6 tender joints at screening and baseline (based on 66/68-joint count)
Diagnosis of RA for \>=3 months and also fulfills the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria for RA
Demonstrated an inadequate response or loss of response to or intolerance to \>=1 conventional synthetic disease-modifying antirheumatic drug (csDMARD)

Exclusion

Have failed more than two TNF inhibitors or JAK inhibitors
Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)
Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab
Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy, whichever is longer, prior to initiation of study treatment.
History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA
Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug
History of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of the study drug (or its excipients) and/or other products in the same class
Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
Any serious, chronic and/or unstable pre-existing medical, psychiatric, or other- condition
History of malignancy, with the exception non-metastatic basal cell or cutaneous squamous cell cancer adequately treated with electrodesiccation and curettage or resection or in situ cervical cancer adequately treated and cured
Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections
History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
History of organ transplant
Any identified confirmed congenital or acquired immunodeficiency
Abnormal laboratory values and liver function test

What this trial measures

  • Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP)Baseline, At Week 14